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PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate 0.05% and 0.015% Gel Followed by Hand Washing in Healthy Subjects.


Phase 1
18 Years
N/A
Not Enrolling
Both
Healthy, Actinic Keratosis

Thank you

Trial Information

PEP005 Gel - Evaluation of Local Tolerability After Exposure to Ingenol Mebutate 0.05% and 0.015% Gel Followed by Hand Washing in Healthy Subjects.


Inclusion Criteria:



- Must be male or female and at least 18 years of age

- Female patients must be of: non-childbearing potential or if of childbearing
potential then have a negative serum and urine pregnancy test and using effective
contraception

- Ability to provide informed consent

Exclusion Criteria:

- Have received treatment with immunomodulators, or interferon/interferon inducers or
systematic medications that suppress the immune system in the last 4 weeks

- Exposed to prescribed systemic (take as tablet, injection etc) or topical (gel,
cream, lotion) medication within the last 7 days

- Have any signs of skin irritation or damaged skin at or around the dominant index
finger

- Have worked in an occupation with a high risk of being in contact with irritative
material (eg. chemicals, painting) on their hands, especially fingers

- Those who are currently participating in any other clinical trial

- Those known or suspected of not being able to comply with the requirements of the
protocol

- Females who are pregnant or are breastfeeding

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Local Skin Responses

Outcome Time Frame:

Up to 8 days

Safety Issue:

Yes

Principal Investigator

Jonathan Dosik, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

TKL Research

Authority:

United States: Food and Drug Administration

Study ID:

LP0041-01

NCT ID:

NCT01302925

Start Date:

February 2011

Completion Date:

March 2011

Related Keywords:

  • Healthy
  • Actinic Keratosis
  • Keratosis
  • Keratosis, Actinic

Name

Location

TKL ResearchParamus, New Jersey